Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Children
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any - 10 |
| Updated: | 4/21/2016 |
| Start Date: | April 2005 |
| End Date: | November 2006 |
A Phase 2, Randomized, Single-blind, Controlled, Single-Center Study to Compare the Safety and Immunogenicity of One Dose of Chiron Meningococcal ACWY Conjugate Vaccine With One Dose of Licensed Meningococcal ACWY Polysaccharide Vaccine Administered to Healthy Children 2-10 Years of Age and an Open-label Study to Assess the Safety and Immunogenicity of One Dose of Chiron Meningococcal ACWY Conjugate Vaccine Administered to Healthy Toddlers 12-23 Months of Age
The purpose of this study is to evaluate the safety and immunogenicity of Novartis (formerly
Chiron) Meningococcal ACWY Conjugate Vaccine administered to healthy children ages 1 - 10
years
Chiron) Meningococcal ACWY Conjugate Vaccine administered to healthy children ages 1 - 10
years
Inclusion Criteria:
- Group 1: Healthy children 2-10 years of age;
- Group 2: Healthy toddlers 12-23 months of age; who are up to date with age
appropriate immunizations for diphtheria, tetanus, pertussis, polio, hepatitis B,
Hemophilus influenzae type b, and pneumococcus.
Exclusion Criteria:
- Group 1: Subjects with a previous or suspected disease caused by N. meningitidis; or
previous immunization with a meningococcal vaccine or vaccine containing
meningococcal antigen(s); Any serious acute, chronic or progressive disease.
- Group 2: Subjects with a previous or suspected disease caused by N. meningitidis or
previous immunization with a meningococcal vaccine or vaccine containing
meningococcal antigen(s); Any serious acute, chronic or progressive disease.
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